Federal Circuit Hears Argument in CRISPR Patent Priority Dispute

by Wilson Sonsini Goodrich & Rosati

Today, the U.S. Court of Appeals for the Federal Circuit heard argument in University of California v. Broad Institute1 on whether the Patent Trial and Appeal Board (PTAB) correctly held that both the University of California (UC) and the Broad Institute (Broad) are entitled to their separate patents to CRISPR technology.2 CRISPR is a powerful gene editing technology first identified in prokaryotes (for example, bacteria). UC had claims to CRISPR broadly. Broad, however, had claims to the use of CRISPR in eukaryotic cells (including humans cells). The PTAB declared an interference between one UC patent application and 12 Broad-issued patents on the assumption that UC's broad claims and Broad's eukaryote claims were directed to the same invention.3 A patent interference is a proceeding formerly used to determine who first invented a claimed invention. Interferences were phased out in 2012 legislation, but patent applications pending before March 2013 still can be subject to an interference.

After briefing and a hearing, the PTAB issued a judgment terminating the interference without deciding the disputed priority of invention. The PTAB instead determined there was no interference-in-fact because Broad's eukaryote invention would not have been obvious from UC's invention. Hence, the parties' patent claims were not directed to the same invention. UC appealed to the Federal Circuit, a federal appeals court with specialized jurisdiction, including exclusive jurisdiction in patent cases. Chief Judge Prost presided over the hearing, joined by Judge Moore and Judge Schall.

Donald Verrilli, solicitor general in the Obama administration, represented UC. He opened argument by explaining that several other research groups were able to attain success with eukaryotes following UC's lead, using only conventional techniques and common sense. Judge Moore pushed back, noting that most of the issues on appeal involved PTAB fact findings, which are viewed for substantial evidence. The substantial evidence test (which is also used for jury findings) is quite deferential: the court will affirm, even if it might have reached another decision, as long as there is sufficient evidence to support the PTAB's findings.

UC contended that the PTAB lacked such evidence because it made errors of law and ignored considerable contrary evidence. In particular, UC argued that the near-contemporaneous success of others was strong evidence of obviousness. Chief Judge Prost suggested that the PTAB might have applied an excessively stringent test for obviousness, requiring UC to show near certainty that CRISPR would work in eukaryotes.

Broad argued that the PTAB had provided pages of analysis explaining why it found the art too unpredictable at the time in question. Chief Judge Prost asked whether Broad would have lost if the Board had used October 2013 as the proper time for analysis. Broad explained that both parties had briefed the issue using October 2012 as the relevant time. Broad contended that UC's theory on appeal was new and thus waived.

In rebuttal, UC showed where it had raised its present theory before the PTAB. UC conceded that it had also argued for a stronger test at the PTAB, but was no longer pursuing that theory. UC urged that the PTAB had improperly relied on Broad's expert for hypothetical problems, instead of focusing on the success in the art following UC's innovation. Judge Moore, however, suggested that ease of success does not mean it was expected, explaining that researchers commonly try the easiest approaches first to determine whether they work and, if not, obtain experience for further research.

The two most active judges seemed to be heading in opposite directions in how they would resolve the case. Accordingly, the case might well produce a split decision, with the likeliest outcome being an affirmance with a written decision explaining why the PTAB decision was adequate under a deferential standard of review.

1 Appeal No. 17-1907 (Fed. Cir.).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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